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Brief Title: A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
Official Title: A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
Study ID: NCT00373529
Brief Summary: Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.
Detailed Description:
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinical Hospital, Phoenix, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Scripps Cancer Center, San Diego, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Medical College of Georgia, Augusta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mount Sinai School of Medicine, New York, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
West Virginia University - HSC, Morgantown, West Virginia, United States
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR